NEW DELHI, 20 JAN 2026 — The Central Drugs Standard Control Organisation (CDSCO) has launched a significant “clean-up” drive targeting the massive backlog of applications on the cdsco sugam portal. In a public notice issued on January 16, 2026, the regulator warned that applications with unresolved queries will be summarily rejected if manufacturers fail to act within a strict 30-day window.
The Central Drugs Standard Control Organisation (CDSCO) has released a public notice regarding the disposal of long-pending applications awaiting query responses on the cdsco sugam portal. This initiative aims to reduce backlogs across various divisions, including Medical Devices, In Vitro Diagnostics, and Biologics. The notice clarifies that failure to respond to a series of four communications will lead to the application standing rejected, with all fee surrendered.
CENTRAL DRUGS STANDARD CONTROL ORGANISATION (CDSCO) : KEY DETAILS OF THE STRUCTURED REMINDER MECHANISM
The CDSCO has initiated a timeline-based reminder process to inform applicants of pending evaluations. The process includes:
- Three Sequential Reminders: A series of three reminders requesting responses to pending queries within prescribed timelines.
- Final Disposal Notice: A fourth and final communication issued to those who fail to respond after three reminders, informing them of the application’s rejection.
- fee surrendered : Once an application is rejected under this mechanism, the fee amount is forfeited in accordance with applicable provisions.
IMPACT ON THE MEDICAL DEVICES AND IN VITRO DIAGNOSTICS SECTOR
The notice specifically targets long-standing applications that have been pending for several years:
- Medical Devices and IVDs: Applications pending since 2018 are under review.
- Biologics: Applications pending since 2016 are included in this drive.
- Immediate Deadline: Applications that have already received three reminders prior to this notice will be rejected within 30 days of January 16, 2026.
MANDATORY TIMELINES FOR COMPLIANCE
India medical device registration prevent the disposal of old files, stakeholders must adhere to the following schedule for reminders:
- 1st Reminder: Initial customized notice sent regarding the old file.
- 2nd Reminder: Issued 30 days after the 1st reminder.
- 3rd Reminder: Issued 30 days after the 2nd reminder.
- 4th Disposal Notice: Issued 30 days after the 3rd reminder, resulting in application disposal.
HOW COMPANIES CAN AVOID REJECTION
All stakeholders are advised to take immediate action to ensure their applications remain active:
- Audit Pending Queries: Check the SUGAM portal for any outstanding queries from CDSCO.
- Submit Responses Promptly: Ensure all technical responses are submitted through both email and the SUGAM portal.
- Adhere to the 30-Day Window: For applications already notified via three reminders, submit final responses before the mid-February 2026 deadline.